Events

Retiro De Equipo (Recall) de Device Recall SURFIX Fixed Angle Locking Screw

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Integra LifeSciences Corporation.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    68284
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1697-2014
  • Fecha de inicio del evento
    2014-03-28
  • Fecha de publicación del evento
    2014-06-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-04-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127268
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Screw, fixation, bone - Product Code HWC
  • Causa
    New deal has identified through a complaint report that some 3.5 mm diameter x 22 mm length surfix screws in lot no. f626 (catalogue no. 285322s) have been packaged and labeled as 3.5mm diameter x 30 mm length surfix screws (catalogue no. 285330s).
  • Acción
    Integra issued an Urgent Voluntary Medical Device Recall letter dated March 28, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review their inventory for affected product, immediately stopo using or distributing them. Customers were asked to complete the Acknowledgement Form and return by email or fax as indicated on the form. When the form is received customer service will contact customers to provide an RMA number and directions to return the affected products. Customers with questions were instructed to call 1-855-532-1723. For questions regarding this recall call 609-275-2700.

Device

Device Recall SURFIX Fixed Angle Locking Screw
  • Modelo / Serial
    SURFIX 3.5 mm D X 22 mm L /Cat No 285322S Lot no. F6S6;  SURFIX 3.5 mm D X 30 mm L /Cat. No. 285330S Lot no. F6ZL
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA including AR, CA, NC, TX and Internationally to Austria, Chile, Denmark, Finland, France, Germany, Greece, Ireland, Italy ,Lebanon, Portugal, Russia, South Africa, Spain, Switzerland, United Arab Emirates, and United Kingdom.
  • Descripción del producto
    Integra Newdeal SURFIX Fixed Angle Locking Screw 3.5mm x 22mm (catalog number 285322S) and 3.5mm x 30mm (catalog number 285330S). Screws are provided in different diameters and lengths and are used to anchor various sizes and shapes of bone fixation plates when treating bone fractures or reconstruction of the ankle, foot or hand.
  • Manufacturer
    Integra LifeSciences Corporation

Manufacturer

Integra LifeSciences Corporation